A randomized,controlled clinical trial of an intravesical pressure‐attenuation balloon system for the treatment of stress urinary incontinence in females

Aims

Evaluate the efficacy, safety, and tolerability of a novel pressure‐attenuation balloon for the treatment of female stress urinary incontinence (SUI) using a prospective, randomized, single‐blind, multi‐center design, evaluated at 3 months.

Methods

Sixty‐three females with SUI were randomized 2:1 to treatment with a balloon (N = 41) or sham procedure (N = 22). The sham (control) entailed the same procedure without the deployment of a balloon. Endpoints were evaluated at 3 months and included a composite endpoint that required both ≥10 point increase in the 22‐item Incontinence Quality of Life Survey (I‐QOL) and ≥50% decrease in provocative pad weight. Additional endpoints included incontinence episode frequency, and PGII assessment.

Results

In an ITT analysis, 63% of women in the treatment group achieved the composite endpoint, compared to 31% in the Control Group (P = 0.0200). In a per protocol analysis, 81% of women in the treatment arm had a 50% decrease in pad weight test vs. 45% in the Control Group (P = 0.0143); 41.6% of the treatment patients were dry on pad weight test (≤1gram) vs. 0% in the Control Group (P < 0.001), and 58% of treated patients reported improvement on a PGII assessment versus 25% of women in the Control Group (P = 0.025). Adverse events in the treatment group included dysuria (14.6%), gross hematuria (9.8%), and UTI (7.3%).

Conclusions

This minimally invasive treatment for female SUI with an intravesical pressure‐attenuation balloon was safe and effective. The concept of pressure attenuation as a therapy for SUI is valid and feasible for those patients that can tolerate the balloon. Neurourol. Urodynam. 35:252–259, 2016. © 2015 The Authors. Neurourology & Urodynamics published by Wiley Periodicals, Inc.     

Periurethral autologous fat injection as treatment for female stress urinary incontinence: a randomized double-blind controlled trial

PURPOSE: We evaluated the effectiveness of periurethral autologous fat injection as treatment for female stress urinary incontinence. MATERIALS AND METHODS: Women with stress incontinence were randomized in a double-blind fashion to receive periurethral injections of autologous fat (treatment group) or saline (placebo group). After injection patients were evaluated monthly for 3 months by a validated standardized incontinence questionnaire, 1-hour pad test and cough test. Patients who remained incontinent were offered repeat injection using the same initial agent to a maximum of 3 injections. Every 3 months after injection patients were assessed by a standardized questionnaire, pad test, cough test and urodynamics. Those who did not qualify for repeat injection at 3 months were then followed 6, 9, 12, 18 and 24 months or until failure. RESULTS: Of the 68 women enrolled 35 received fat and 33 received saline injections. The groups were comparable in terms of baseline parameters. A total of 56 patients completed the study, including 27 in the fat and 29 in the placebo group, for a total of 189 injections (91 fat and 98 saline). At 3 months 6 of 27 (22.2%) and 6 of 29 (20.7%) women were cured or improved in the fat and saline groups, respectively. Complications included cystitis in 9 of 189 injections, urinary retention in 6 in the fat injection group, urge incontinence in 9 of 68 patients and pulmonary fat embolism resulting in death in 1 of 189 procedures. CONCLUSIONS: In this study periurethral fat injection did not appear to be more efficacious than placebo for treating stress incontinence.     

The 7‐year outcome of the tension‐free vaginal tape procedure for treating female stress urinary incontinence

OBJECTIVE

To evaluate the long‐term results and predictive risk factors for efficacy after the tension‐free vaginal tape (TVT) procedure for treating female stress urinary incontinence (SUI).

PATIENTS AND METHODS

Inall, 306 women (mean age 50.7 years, sd 8.7) who had a TVT procedure for SUI were selected and followed ≥7 years (mean 92.3 months, range 84–110) after surgery. We analysed the long‐term results, the variables predictive of cure rates, and patient satisfaction.

RESULTS

The overall 7‐year cure rate was 84.6%, with a satisfaction rate of 69.3%. The cure rates were lower in patients with high‐grade SUI (50% in grade III, 82.8% in grade II and 90.7% in grade I; P < 0.001). On multivariate analysis, there were no independent risk factors related to cure rate, and urgency was the only factor independently associated with patient satisfaction (P = 0.008; odds ratio 2.47). Seventy‐one patients (23.2%) had complications at the 1‐month follow‐up after surgery, but only eight (2.6%) had complications at the 7‐year follow‐up, including mesh exposure in six and de novo urgency in two.

CONCLUSION

The absence of long‐term adverse events associated with the TVT procedure, and high subjective and objective 7‐year success rates with no independent predictive factors affecting the long‐term cure rate, make the TVT procedure a recommendable surgical treatment for female SUI.     

压力性尿失禁患者的尿流动力学研究

目的　了解压力性尿失禁患者的尿流动力学特点,为明确诊断及合理治疗提供参考。方法　对临床诊断为压力性尿失禁的30例患者进行系统尿流动力学研究,并与正常对照组(30 例)比较。结果　两组最大尿流率分别为(30.12±9.81)mL/s、(18.70±8.31)mL/s,平均尿流率分别为(15. 18±7. 22) mL/s、(12. 30±7. 21) mL/s,初感容量分别为(175. 20±57. 34) mL、(165.70±40.65)mL,强烈尿感容量分别为(354.83±52.83)mL、(339.20±50.84)mL,最大尿道闭合压分别为(84.93 ±45.81)cm H2O、(110.23±32.26)cm H2O,压力性尿失禁组测得Valsalva漏尿点压力(73.70±22.61) cm H2O,出现异常尿流曲线7例(23.3%),残余尿 10 例(33. 3%),合并逼尿肌不稳定性收缩 3 例(10%),肌电图协同失调 5 例(16. 7%),正常对照组均无。结论　压力性尿失禁患者是一个复杂的群体,尿流动力学检查对于明确其诊断,选择正确的治疗方法,提高治疗效果有着重要意义。     

A prospective observational trial of pelvic floor muscle training for female stress urinary incontinence

OBJECTIVE: To assess the impact of pelvic floor muscle training (PFMT) on bladder neck mobility in a prospective observational study, and to correlate any observed changes with objective, standardized outcome measures of the severity of stress urinary incontinence (SUI). PATIENTS AND METHODS: Women with the symptom of SUI were recruited prospectively over a 3-year period from a tertiary referral urogynaecology clinic in a teaching hospital. A group of 97 treatment-naive women complaining of SUI and confirmed as having urodynamic SUI on video-urodynamic assessment agreed to participate. Bladder neck mobility on perineal ultrasonography was assessed immediately before and on completing a 14-week programme of 'PFM rehabilitation'. Treatment outcome was assessed using a standardized pad-test and a condition-specific, validated quality-of-life questionnaire (King's Health Questionnaire). Changes in functional anatomy were quantified using transperineal ultrasonography to measure the bladder neck position at rest, maximum PFM contraction and maximum Valsalva manoeuvre. Bladder neck rotational mobility from rest to maximum incursion and maximum excursion was calculated. RESULTS: Treatment with an intensive package of PFMT and behavioural modification resulted in significant elevation of the bladder neck position at all three measured positions. Displacement of the bladder neck on Valsalva (rotational excursion) was reduced after treatment, suggesting increased levator 'stiffness'. These changes in functional anatomy were associated with a statistically and clinically significant reduction in urine loss and improvement in condition-specific quality of life. CONCLUSION: The present results show that PFMT is an effective treatment for SUI and provide an important new insight into how dynamic pelvic floor anatomy can be modified by this widely used intervention.     

TVT-O治疗女性压力性尿失禁长期疗效分析

目的 探讨由内向外经闭孔尿道中段无张力悬吊术(TVT-O)治疗女性压力性尿失禁(SUI)的长期疗效.方法 分析2004年8月至2006年8月应用TVT-O手术治疗68例女性SUI患者的临床和随访资料,探讨TVT-O术后至少6年的治愈率及常见并发症.结果 以尿失禁症状消失和咳嗽试验阴性定义为临床治愈,在TVT-O术后6周、1年和6年的治愈率分别是85.3％(58/68)、82.4％(56/68)和80.9％(55/68),差异无统计学意义(P＞0.05).术后排尿困难3例,新发尿急4例,大腿根部和腹股沟区疼痛13例,均行相关处理.术后复发3例,采用其他疗法.结论 TVT-O是治疗女性SUI的有效术式,其长期疗效持续稳定.TVT-O严重并发症少见,但术后腹股沟疼痛需引起高度重视.     

Short‐term assessment of a tension‐free vaginal tape for treating female stress urinary incontinence

OBJECTIVE

To evaluate the short‐term surgical complications and results of a tension‐free vaginal tape (TVT) system (TVT‐Secur^TM, Gynecare, Ethicon, Somerville, NJ, USA) in the treatment of female stress urinary incontinence (SUI).

PATIENTS AND METHODS

TVT‐Secur was applied to 107 women with SUI through a vaginal incision and left abutting the urethra. Postoperative pain, complications, de novo lower urinary tract symptoms, incontinence cure rate and the King’s Health Questionnaire (KHQ) score were evaluated.

RESULTS

The operative duration was 12 min; the mean pain score was 2.3 and only one patient had transient voiding difficulties. After a mean follow‐up of 15 months, 71% of the patients were dry and 14% improved. The KHQ scores decreased significantly for most subscores. Urgency appeared de novo in six patients (5.6%), and vaginal erosion required one TVT‐Secur explantation.

CONCLUSION

This study shows that TVT‐Secur is a simple and safe treatment for female SUI, but before recommending this sling as a first choice for treating SUI, TVT‐Secur must pass the test of time and comparative studies with conventional slings.     

TVT-Abbrevo~(TM)吊带术治疗女性压力性尿失禁的疗效观察

目的:探讨TVT-AbbrevoTM吊带手术治疗女性压力性尿失禁(SUI)的疗效及安全性。方法:2013年5~8月共收集SUI患者16例,应用TVT-AbbrevoTM吊带系统进行治疗,记录并分析所有患者的临床资料,包括治愈率、满意度和手术并发症等。结果:16例手术均获得成功,手术时间19~45min,失血量15~30ml。术中无膀胱、尿道、肠管、阴道等损伤,无会阴血肿和切口感染,无排尿困难、新发尿急。2例大腿根部酸痛,未予特殊治疗自然消失;1例术后排尿困难,经留置尿管48小时后,症状消失;1例术后尿频,口服舍尼亭4mg,每日2次,2周后尿频消失。16例尿失禁均消失,咳嗽试验阴性,随访1~12周无复发。结论:TVT-AbbrevoTM吊带手术治疗女性压力性尿失禁,并发症少,近期疗效良好。     

Long‐term efficacy of the bone‐anchored male sling for moderate and severe stress urinary incontinence

Study Type – Therapy (outcomes research)
Level of Evidence 2c

OBJECTIVE

To present a prospective long‐term evaluation of the bone‐anchored male sling (InVance^TM, American Medical Systems, Minnetonka, MN, USA) for patients with moderate to severe stress urinary incontinence (SUI) after prostate surgery

PATIENTS AND METHODS

Forty‐five patients had a male sling implanted for SUI after prostate surgery. The evaluation before and after surgery included a complete history and physical examination, various questionnaires (American Urological Association Symptom Score, University of California Los Angeles/RAND prostate index), cysto‐urethroscopy, International Continence Society (ICS) 1‐h pad test and a urodynamic study. The follow‐up assessments were at 2, 6 and 12 months after surgery, and yearly thereafter. The success rate was defined as the percentage of patients ‘dry’ and ‘improved’.

RESULTS

The median (range) follow‐up was 36 (2–64) months. Twelve patients (27%) had previous adjuvant radiotherapy. Eighteen patients (40%) had moderate SUI (two or three pads/day) and 27 (60%) had severe SUI (more than three pads/day). All preoperative ICS 1‐h pad tests were positive. The success rate was 76%; 16 patients were dry (36%), 18 were improved (one or two pads/day, 40%) and in 11 the sling was a failure (24%); 76% of ICS 1‐h pad tests were negative after surgery. The postoperative urodynamic study showed no signs of bladder outlet obstruction. In all, 72% of patients were satisfied/very satisfied with the surgery and 86% considered themselves cured/almost cured. The success rate was not affected by the presence of previous radiotherapy or the severity of SUI. Ten patients had perineal numbness, but in all it resolved within 1–3 months. There was one mesh infection which required its removal. There was no urethral erosion.

CONCLUSION

Compared to previous studies, the InVance male sling had a good success rate for moderate and severe SUI, with a median follow‐up of 36 months. The results did not differ for moderate or severe SUI or with the presence of previous radiotherapy.     

Comparative data from history,clinical examination and urodynamics in patients with genuine stress urinary incontinence and recurrent stress urinary incontinence after surgery

In this study 272 patients with genuine stress urinary incontinence (GSUI) were initially considered. Of these, 247 were divided into three groups based on: positive history for GSUI (group 1); positive history and clinical examination for GSUI (group 2); and positive history, clinical examination, and cough urethral pressure profile for GSUI (group 3). When compared with a group of 30 normal women (control group) the values for the urethral functional length (FL) and the maximum urethral closure pressure (MCUP) decreased progressively from group 1 to group 3. The pressure transmission ratio (PTR) was signficantly lower only in group 3.Tonometric values calculated for a group of 25 patients with GSUI recurring afterprevious surgical correction (group 4) were found to be comparable with group 3. These patients with recurrent GSUI had a FL decreased to 70% and a MCUP decreased to 48% of the normal values. The PTR was maintained at a normal value of 97% in patients with degree I recurrence, but was decreased to 68% in patients with degree II–III recurrence having the most severe impairment of the periurethral environment.     

亲水性聚丙烯酰胺凝胶腔内注射治疗女性压力性尿失禁

目的 评估亲水性聚丙烯酰胺凝胶(生物凝胶)经尿道腔内注射治疗女性压力性尿失禁的疗效。方法 24例女性压力性尿失禁患膀胱镜直视下于后尿道近膀胱开口0．5-lcm的3,6，9点处黏膜下穿刺注射生物凝胶平均12．2(6．20)ml／次。结果 腔内注射一次18例，二次5例，三次1例，累积平均注射量18．9(6—38)ml。术后尿道平均延长1．03cm，膀胱颈部尿道121周径平均缩小3．1lcm，症状消失13例，占54．2％；改善11例，占48．5％；无并发症和不良反应发生。结论 生物凝胶腔内注射治疗女性压力性尿失禁疗效确切，创伤微小，可重复注射，可选择为压力性尿失禁的外科治疗方法。     

Single-incision sling system as primary treatment of female stress urinary incontinence: prospective 12 months data from a single institution

Study Type – Therapy (case series) Level of Evidence 4 What's known on the subject? and What does the study add? Single‐incision slings (SIS), requiring very limited intracorporeal dissection, have been recently introduced on the premise that they might increase safety of female stress urinary incontinence treatment. However, their success rate has been insufficiently evaluated. This is a large prospective series on Mini‐Arc SIS, with data on 105 patients available at a mean follow‐up of 12 months. Success rates are comparable while morbidity was lower and milder than that associated retropubic or transobturator slings. This study warrants a large‐scale randomized comparative study between Mini‐Arc and standard mid‐urethral tapes, matured at longer follow‐up time.

OBJECTIVE

? To investigate the success and complication rates for Mini‐Arc^TM single incision sling in the treatment of female stress urinary incontinence (SUI).

MATERIALS AND METHODS

? A total of 119 female patients with pure SUI were enrolled in a prospective study. From these, 105 were available with a minimum follow‐up of 6 months and a mean follow‐up of 12 months. ? Success, as determined by patient‐ reported outcomes, and complication rates, as well as impact of learning curve, body mass index (BMI), intrinsic sphincter deficiency (ISD), incontinence severity and age were investigated.

RESULTS

? Cure rate was 80% and improvement rate was 11%. Pain intensity was minimal on a visual analogue scale and transient urinary retention occurred in three patients, one requiring sling section. ? De novo urgency was reported by 6% of women. Severe incontinence was less likely to be cured: 70% if >5 pads per day (ppd); 94% if <2 ppd; 94% if 2–4 ppd, P < 0.05). ? There was no difference in success rates between the first 50 and the last 50 patients. BMI, ISD and age also did not influence success rate.

CONCLUSION

? Mini‐Arc^TM attained high success rates at 1 year follow‐up. The procedure was easy to learn and was associated with very low and mild morbidity. Severe incontinence was identified as a risk factor for failure.     

无张力尿道中段悬吊术治疗女性压力性尿失禁84例临床分析

目的 探讨经阴道无张力尿道中段悬吊术(TVT)治疗女性压力性尿失禁(SUI)的临床疗效.方法 女性SUI患者84例,经临床病史收集、尿动力学检查及生活质量评分等确诊.采用TVT将聚丙烯吊带无张力置于尿道中段,对其中15例阴道壁脱垂患者同时行阴道壁修补术.测定患者TVT手术前后尿动力学检查、生活质量评分以及总体手术疗效在术后随访期限内的变化.结果 75例患者按时进行复诊,9例患者因年龄或居住外省等原因进行电话随访.随访时间1月至11年,通过主观及客观检查证实72例(85.7％)治愈,9例(10.7％)好转,3例(3.6％)无效.11年随访过程该数值较为稳定(P＞0.90).在多变量分析中,肥胖(HR:2.61,P=0.03)及盆底手术史(HR:0.33,P=0.001)是SUI术后复发的独立危险因素.随访过程没有出现需外科手术干预的并发症.结论 TVT因其微创、操作简便、并发症少及术后恢复快、临床疗效稳定成为女性压力性尿失禁外科手术的首选手术术式.